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Recall Observatory FDA recall evidence

Drug product

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11.

D-0815-2016

February 16, 2016

Class II

Product summary

Firm
Actavis Elizabeth LLC
Event
Event 73474
Status
Terminated
Classification
Class II
Quantity
182,378 Bottles
Official record key
drug-enforcement:D-0815-2016

Official wording

Reason: Failed Impurities/Degradation Specifications: Out of specification for impurities.

Code information: Lot #: 1879E141, Expiry 02/16; Lot #: 1880E141, Expiry: 02/16; Lot #: 5034M142; Expiry: 5/16; Lot #: 0422A151, Expiry: 7/16; Lot #: 0423A151, Expiry: 7/16; Lot #: 1053C151, Expiry: 8/16; Lot #: 1054C151, Expiry: 8/16; Lot #: 2197E152, Expiry: 11/16; Lot #: 2198E151, Expiry: 12/16; Lot #: 2662F151, Expiry: 12/16; Lot #: 2672F152, Expiry: 3/17; Lot #: 3121G152, Expiry: 3/17; Lot #: 3798J151, Expiry: 4/17; Lot #: 5104M151, Expiry: 5/17.

Distribution pattern: US: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification